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LEAP-017: Lenvatinib and Pembrolizumab in MSS mCRC


The LEAP-017 trial results presented at ESMO GI 2023 are explored by Dr Marshall.

John L. Marshall, MD: There is an early observation that VEGF [vascular endothelial growth factor] inhibition along with IO [immune-oncology] therapy has been useful. Genentech has a combination of atezolizumab and bevacizumab, both monoclonal antibodies. So others are thinking, “Could we somehow coordinate these mechanisms to have better benefit for patients?” And the whole LEAP series is a combination of lenvatinib, an oral agent, which has some VEGF qualities to it, combined with pembrolizumab, an IO monoclonal antibody. And there have been some signals in a variety of clinical settings where these medicines are actually [offering] some benefit to patients. The [LEAP-017] study [NCT04776148] was presented [at the European Society for Medical Oncology World Congress on Gastrointestinal Cancer], and we were all eager and excited for this because, fingers crossed, somebody may have come up with a better way to go at this. This study was a large, randomized study of refractory disease of the doublet lenvatinib and pembrolizumab against physician’s choice of other available agents. Sort of the Lonsurf [trifluridine and tipiracil] or Stivarga [cabozantinib] kinds of approaches, the standard of care. Big study. Nearly 500 patients enrolled with an overall survival primary end point. And as with a lot of these studies, we’re excited. We’re excited, and then we’re sort of let down. This did not end up winning against our current standard of care. Validating our standard of care didn’t really lose to our standard of care, but it didn’t win. So we saw a tie, I guess, in these treatments. And remember, this is in the microsatellite-stable patient population where these immunotherapies are not supposed to work very well. And there was a trend toward survival and PFS [progression-free survival] and response, but it didn’t meet the statistical threshold for a win. So it’s a letdown a little bit, but it’s also that signal that says there’s something there and worth continuing to try and figure out why and who should get these therapies.

Transcript edited for clarity.

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